Pharmaceuticals Policy and Law - Volume 20, issue 1-4

Authors: Martin Casals, M. | Valverde, J. L.

Article Type: Editorial

DOI: 10.3233/PPL-180474

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 1-3, 2018

Authors: Martín-Casals, Miquel

Article Type: Research Article

Abstract: The European Union, the United States Japan and Brazil have developed different product liability rules which, in spite of showing some trends towards harmonisation, still make it impossible for manufacturers of pharmaceuticals to implement globally acceptable product designs, manufacturing processes and labelling. In the products liability rules for pharmaceuticals there are still differences as regards the contract/tort approach, the use of alternative instruments of no-fault compensation schemes, the need to establish specific rules for some sort of pharmaceuticals and the understanding of some of the core elements of products liability such as the notions of product, defect, causation and defences. …This paper deals with some of these questions from a comparative prospective trying thereby to establish a general framework for some of the problems that will be dealt with in more detail in the other papers included in this issue. Show more

Keywords: Liability for pharmaceutical products, comparative law, contract/tort rules, no-fault compensation schemes, specific rules for pharmaceuticals, product, defect, causation, defences

DOI: 10.3233/PPL-180464

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 5-22, 2018

Authors: Robinette, Christopher J. | Green, Michael D.

Article Type: Research Article

Abstract: Pharmaceutical claims are arguably the most significant type of product liability cases in the United States. Failure to warn is the primary theory used against pharmaceutical manufacturers, and it can be brought under strict product liability or negligence; the standard is essentially the same under either doctrine. In this descriptive overview of United States law, the authors discuss theories of recovery, causation, damages, defences, procedure, and alternative regulations and remedies.

Keywords: Product liability, pharmaceuticals, failure to warn

DOI: 10.3233/PPL-180473

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 23-39, 2018

Authors: Shapo, Marshall S.

Article Type: Research Article

DOI: 10.3233/PPL-180472

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 41-58, 2018

Authors: Nagano, Fumihiro | Karaiskos, Antonios

Article Type: Research Article

Abstract: The Japanese liability system regarding pharmaceutical products consists of two basic categories: the general fault-based liability is accompanied by the liability system based on the Product Liability Act (PLA), which is established under the influence of American doctrine and the EC directive. The PLA liability is originally supposed to be a strict liability, but this characterisation is recently more and more doubted. The other features of Japanese law relating to pharmaceutical products liability include some state-operated compensation schemes, several measures to facilitate proof, development risk defence, lack of market share liability and class action.

Keywords: Strict liability, manufacturing defect, design defect, information or warning defect, facilitation of proof, development risk, alternative dispute resolution (ADR), non-pecuniary damage

DOI: 10.3233/PPL-180471

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 59-74, 2018

Authors: Peteffi da Silva, Rafael

Article Type: Research Article

Abstract: This article will address the issue of pharmaceutical liability in Brazilian law. At first, the article will describe the general lines of product liability in Brazilian law, addressing the main requirements for victims’ compensation, as well as the main defenses that product suppliers can use. Subsequently, this article will show the specific characteristics of pharmaceutical liability, addressing mainly the specificities of inherently dangerous products. Finally, the most important and current jurisprudence on the subject will be commented

Keywords: Tort law, pharmaceutical liability, product liability, inherently dangerous products

DOI: 10.3233/PPL-180465

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 75-87, 2018

Authors: Jacquemin, Zoé

Article Type: Research Article

DOI: 10.3233/PPL-180466

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 89-102, 2018

Authors: Magnus, Ulrich

Article Type: Research Article

Abstract: In 1976 Germany introduced a special strict liability regime for personal injuries through pharmaceuticals for human consumption. This was in reaction to the Thalidomide-catastrophe in the 1950ies and 1960ies. Since then, Germany disposes of a two lane-system of liability in this field: traditional fault liability under general tort law and strict liability under the special Medicinal Products Act. The following article examines in detail the conditions of liability under either regime. Also, possible defences and procedural matters are being dealt with as well as the question of insurance and the accessibility of funds established for victims.

Keywords: Liability for defective medicinal products, special statutory regulation in Germany, strict liability, causation and damages, fund solutions, producers’ defences and time limits

DOI: 10.3233/PPL-180470

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 103-114, 2018

Authors: Goudkamp, James

Article Type: Research Article

Abstract: This short article addresses a series of questions regarding pharmaceutical products liability in the United Kingdom. Issues in both the relevant substantive and procedural law are discussed. The overall picture that emerges is that claims for damage caused by pharmaceutical products are exceptionally challenging. This is due not only, in particular, to a general reluctance on the part of judges to find fault in the design of pharmaceutical products but also the exceptionally high cost of litigation in the United Kingdom.

Keywords: Product liability, pharmaceuticals, consumer protection, failure to warn, defences

DOI: 10.3233/PPL-180469

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 115-129, 2018

Authors: Machnikowski, Piotr

Article Type: Research Article

Abstract: The article discusses product liability law in Poland with regard to liability for pharmaceutical products. The author describes substantive law provisions and their interpretation by Polish and EU courts, procedural issues as well as the impact of safety regulations on civil law liability.

Keywords: Liability, Poland, pharmaceutical products, damage, compensation

DOI: 10.3233/PPL-180467

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 131-141, 2018

Authors: Solé Feliu, Josep

Article Type: Research Article

Abstract: This paper aims at describing the different liability regimes applicable to damages caused by pharmaceutical products. Special attention is paid to the strict liability regime foreseen in the European Directive 85/374/CEE, on the liability of the manufacturer for defective products. It also deals with some of the main characteristics of the Spanish procedural system, when referred to tort liability procedures aimed at compensating damages caused by defective products.

Keywords: Tort law, product liability, pharmaceutical products

DOI: 10.3233/PPL-180468

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 143-161, 2018

Authors: Koch, Bernhard A.

Article Type: Research Article

Abstract: The EC Product Liability Directive includes an optional development risk defence whose requirements are not entirely clear under the directive’s wording. The Court of Justice of the EU has so far had no opportunity yet to clarify its meaning. This article gives a brief overview of the various aspects of this defence.

Keywords: Product liability, development risk, state of the art

DOI: 10.3233/PPL-180463

Citation: Pharmaceuticals Policy and Law, vol. 20, no. 1-4, pp. 163-176, 2018